NCT01994239进行中（未招募）2 期
A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 120
- 试验地点
- 39
- 主要终点
- The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
研究概览
简要总结
The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.
详细描述
Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy.
122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:
- Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy
- Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage)
- •Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage
- •PSA ≤2 ng/mL at moment of the randomisation
- •No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
- •Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
- •Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
- •Creatinine <140 µmol/L (or clearance >60 mL/min)
- •Normal fasting glucose
- •Eastern Cooperative Oncology Group (ECOG) ≤1
- •Age >18 years
- •Life expectancy ≥10 years
- •Patients with invasive cancer in complete response for more than five years are eligible
- •Patients who have received the information sheet and signed the informed consent form
- •Patients with a public or a private health insurance coverage
排除标准
- •Prostate cancer histology other than adenocarcinoma
- •Patients pN1, N1 and M1
- •History of pelvic radiotherapy
- •Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
- •Testosterone ≤0.5 ng/mL
- •History of surgical castration
- •Previous treatment by hormonotherapy
- •Antineoplastic treatment in progress
- •History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
- •Known pituitary adenoma
- •Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic)
- •Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec
- •Individual deprived of liberty or placed under the authority of a tutor
- •Unable to undergo medical monitoring test for geographical, social or psychological reasons
- •Known hypersensitivity to the treatment in test
- •Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this
研究组 & 干预措施
Radiation
Active Comparator
Pelvic radiotherapy
- 46 Gy in 23 fractions of 2 Gy.
- prostate only-boost up to 66 Gy
干预措施: Pelvic Radiotherapy (Radiation)
Radiation and Degarelix
Experimental
Radiotherapy:
- 46 Gy in 23 fractions of 2 Gy.
- prostate only-boost up to 66 Gy
Associated with hormonal therapy by degarelix:
- beginning in parallel to radiotherapy for 6 months
- First dose of 240 mg
- Maintenance dose of 80 mg
干预措施: Degarelix (Drug)
Radiation and Degarelix
Experimental
Radiotherapy:
- 46 Gy in 23 fractions of 2 Gy.
- prostate only-boost up to 66 Gy
Associated with hormonal therapy by degarelix:
- beginning in parallel to radiotherapy for 6 months
- First dose of 240 mg
- Maintenance dose of 80 mg
干预措施: Pelvic Radiotherapy (Radiation)
结局指标
主要结局
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
时间窗: 5 years
次要结局
- Survival without clinical event(5 years)
- kinetics of testosterone(up to 12 months after the end of the radiotherapy and after biological release)
- Overall survival(5 years)
- Patient Quality of life(up to 5 years after the end of the radiotherapy)
- Acute and late toxicities of the association of hormone therapy with radiotherapy(up to 5 years)
- Toxicities of radiotherapy(up to 5 years)
- Survival without biological event(5 years)
- Survival without metastases(5 years)
研究者
研究点 (39)
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